Radiofrequency Ablation Combined With Chemotherapy for Pulmonary Tumors

NSCLC Clinical Trial

— FACPT  

Official title:

A Prospective Study of Radiofrequency Ablation Combined With Chemotherapy for Pulmonary Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01105182
• Other study ID #: FAHG20100201
• Status: Recruiting
• Phase: N/A
• First received: April 12, 2010
• Last updated: April 15, 2010
• Start date: November 2009
• Est. completion date: June 2011

Study information

• Verified date: December 2009
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Weiqiang Yin, MD
• Phone: +86-20-833 37792
• Email: dryin2010[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess short and long term outcomes after radiofrequency ablation (RFA) combined with chemotherapy for pulmonary malignancies in patients who are not candidates for surgical resection. This study will evaluate the efficacy of RFA combined with chemotherapy for the treatment of lung tumors by assessing its impact on local tumor control, progression free survival, overall survival, dyspnea score and quality of life (QOL).

Description:

Percutaneous image-guided RFA is a minimally invasive technique used to treat solid tumours. Because of its ability to produce large volumes of coagulation necrosis in a controlled fashion, this technique has gained acceptance as a viable therapeutic option for unresectable liver malignancies. Recently, RFA has been proposed as a viable option for the treatment of pulmonary malignancies. Experimental studies in animal tumor models have confirmed the effectiveness of RFA in the destruction of experimentally-induced pulmonary malignancies. Pilot clinical investigations have suggested that the treatment can achieve high proportions of tumor response. We designed a prospective clinical trial aimed at assessing feasibility, safety and effectiveness of RFA combined with chemotherapy in the treatment of lung malignancies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• adult (> 18 years) male or female patient

• patient has biopsy-proven NSCLC or lung metastasis

• patient has been rejected for surgery and has been considered unfit for radiation therapy

• each 6 cm or smaller in greatest diameter of tumor, by CT scan

• tumors are located at least 1 cm from trachea; main bronchi; esophagus; aorta; aortic arch branches; pulmonary artery; and heart

• tumors are accessible by percutaneous route

• patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

• patient has platelet count > 100 x 109 /L and international normalized ratio = 1.5

• patient has signed written informed consent prior to any study specific procedures.

Exclusion Criteria:

• patient is considered at high-risk for RF ablation due to major co-morbid medical conditions

• patient has more than 3 tumors / lung

• patient has at least one tumor > 6 cm in greatest diameter

• tumor is associated with atelectasis or obstructive pneumonitis

• patient has renal failure requiring hemodialysis or peritoneal dialysis

• patient has active clinically serious infection

• patient has history of organ allograft

• patient has history of substance abuse or any medical, psychological or social conditions that may interfere with his / her participation in the study or evaluation of the study results

• patient is pregnant or breast-feeding

• patient has ECOG performance status > 2

• patient has platelet count = 100 x 109 /L or international normalized ratio > 1.5.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Neoplasms
• NSCLC
• Pulmonary Metastases

Intervention

Procedure:
• Radiofrequency Ablation
Radiofrequency ablation is an inpatient procedure typically requiring one overnight stay in the hospital.

Locations

Country	Name	City	State
China	Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		3 months	No
Secondary	Overall survival		3 months	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		30 days	Yes